Hinged needle shield assembly having needle cannula lock

ABSTRACT

A needle shield assembly and method of manufacturing a needle shield are provided. The needle shield assembly includes a needle hub having a needle cannula extending therefrom. A needle shield base is pivotably coupled to the needle hub. A locking assembly including a needle engagement member is coupled to the needle shield base. One or both of the needle shield base and the locking assembly include a cavity for receiving the needle cannula. The needle shield is manufactured by providing a needle shield base and a separate locking assembly including a needle engagement member, and connecting the locking assembly to the distal end portion of the needle shield base.

FIELD OF THE INVENTION

[0001] The field of the invention relates to needle shield assembliesfor medical devices such as hypodeimic needles, and to methods formanufacturing such assemblies.

BACKGROUND OF THE INVENTION

[0002] Accidental needle sticks from used hypodermic needles cantransmit disease. Accordingly, various types of needle shields have beendesigned to reduce the possibility of accidental needle sticks.

[0003] A needle shield that is hinged near the base of the needle hasthe advantage of allowing one handed needle reshielding. A number ofprior art needle shield assemblies include hinged needle shields.

[0004] Various means have been provided for locking a hinged needleshield in the closed, needle protecting position. Deflectable membershave been provided in the needle shield for engaging the needle uponshielding and preventing subsequent unshielding of the needle. Suchmembers trap the needle within the needle shield. Locking has also beenaccomplished by locking engagement of the needle shield with the needlesupport structure.

SUMMARY OF THE INVENTION

[0005] A needle shield assembly of the present invention includes aneedle cannula that is secured to the distal end of a needle hub havinga proximal end, a distal end. The hub may be provided with a proximalend for connecting to a medical device such as a syringe. A needleshield base is pivotably coupled to the needle hub. A discrete lockingassembly having one or more locking members for engaging the needlecannula is provided. The locking assembly is coupled to the distal endportion of the needle shield base such that the one or more lockingmembers are lockingly engageable with the needle cannula. At least oneof the needle shield base and locking assembly include a cavity forreceiving at least part of the needle cannula.

[0006] In a first embodiment of the invention, the needle shield basehas a first cavity and the locking assembly includes a cap defining asecond cavity. The cap is secured to a part of the needle shield basesuch that the first and second cavities are contiguous and the one ormore locking members thereof are engageable with the shaft of the needlecannula.

[0007] In a second embodiment of the invention, the needle shield baseand locking assembly are constructed such that they can be coupled at aplurality of locations. The positioning of the locking assembly withrespect to the needle shield allows the locking member(s) of the lockingassembly to be positioned to engage the needle cannula when the shieldis pivoted to the closed position. Relatively long or short needlecannulas can be accommodated.

[0008] A third embodiment of the invention includes a needle shield baseincluding means for coupling to a locking assembly. The locking assemblycan be chosen to engage a needle of selected length.

[0009] A method of manufacturing needle shield is also provided. Themethod includes the steps of providing a needle shield base including aconnector for pivotably connecting it to a medical device, providing alocking assembly having a needle engagement member, and coupling theneedle shield base to the locking assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is a top perspective view showing a needle shield assemblyin accordance with a first embodiment of the invention;

[0011]FIG. 2 is an exploded, top perspective view showing parts of theneedle shield assembly in combination with a medical fluid deliverydevice;

[0012]FIG. 3 is an exploded, bottom perspective view of the needleshield assembly and fluid delivery device of FIG. 2;

[0013]FIG. 4 is a perspective view showing the needle shield assemblymounted to a medical fluid delivery device, the needle cannula of theassembly being exposed;

[0014]FIG. 5 is a perspective view thereof showing the needle shield ina protective position covering the needle cannula;

[0015]FIG. 6 is a cross-sectional view of the needle shield assembly andthe medical fluid delivery device showing the needle shield in a firstposition;

[0016]FIG. 7 is a cross-sectional view thereof showing the needle shieldpartially rotated towards a protective position;

[0017]FIG. 8 is a cross-sectional view thereof showing the needle shieldin a protective position covering the needle cannula;

[0018]FIG. 9 is a cross-sectional view of a locking assembly for theneedle shield taken along line 9-9 of FIG. 8;

[0019]FIG. 10 is a top perspective view of a needle assembly to whichthe needle shield can be mounted;

[0020]FIG. 11 is a top perspective view thereof taken from a differentpoint;

[0021]FIG. 12 is a cross-sectional view of the needle hub and basemember;

[0022]FIG. 13 is a side elevation view of a needle shield showing apartition line;

[0023]FIG. 14 is a cross-sectional view thereof taken along line 14-14of FIG. 13.

[0024]FIG. 15 is a side elevation view of a needle shield cut to a firstselected length;

[0025]FIG. 16 is a side elevation view of a needle shield cut to asecond selected length;

[0026]FIG. 17 is an exploded, perspective view of an alternativeembodiment of the needle shield assembly;

[0027]FIG. 18 is an exploded, perspective view of a second alternativeembodiment of the needle shield assembly;

[0028]FIG. 19 is an exploded, perspective view thereof showing thelocking assembly mounted to the needle shield in a different orientationfrom that shown in FIG. 13;

[0029]FIG. 20 is a cross-sectional view thereof taken along line 20-20of FIG. 19;

[0030]FIG. 21 is a partially exploded side elevation view of a thirdalternative embodiment of the needle shield assembly secured to amedical device;

[0031]FIG. 22 is a top perspective view of the locking assembly thereof,and

[0032]FIG. 23 is a top plan view thereof.

DETAILED DESCRIPTION OF THE INVENTION

[0033] There is shown in the drawings and described below in detailpreferred embodiments of the invention with the understanding that thepresent disclosure is to be considered as exemplary of the principles ofthe invention and is not intended to limit the invention to theembodiments illustrated.

[0034] Referring to FIGS. 1 and 2, a needle shield assembly 20 isprovided that includes a needle hub 22, a base member 24 connected to orintegral with the needle hub, a needle shield base 26, and a needlecover 28. The needle shield base includes a proximal end portion thatcan be connected to the needle hub or base member, and a relativelydistal end portion 27 that includes an elongate cavity for enveloping atleast part of a needle cannula 30. The proximal end portion of theneedle shield base 26 includes an integral hinge pin 29 and a curvedupper surface 31. The upper surface 31 is designed for engagement by auser's finger in order to rotate the needle shield about the hinge pin.Projections 33 may be provided on the curved upper surface.

[0035] Needle cannulas are available in many different lengths andgauges as they maybe used for different purposes. If the needle shieldis to be locked in the protective position by the engagement of alocking member engaging the needle shaft, it is important that thelocking member (or members) be positioned properly. The needle shieldbase 26 of the invention, being either molded to a desired length or cutto length following the molding process, allows it to be customized fora particular needle cannula length.

[0036] A discrete locking assembly 32 including a locking member 34 isprovided for attachment to the distal end portion of the needle shieldbase 26. The locking assembly 32 is comprised of a cap 36 that has agenerally U-shaped cross section and that defines a cavity 38, as shownin FIG. 9. The cavity 38 of the cap is axially aligned with the elongatecavity of the needle shield base 26 when the cap is coupled to theneedle shield base, as shown in FIG. 3. It will be understood that therelative lengths of the distal end portion of the needle shield base andthe cap 36 may be different from those shown in the drawings, and thateither can be longer than the other or the same length as the other.While there is no locking member in the needle shield base of thepreferred embodiment shown in the drawings, both the cap and needleshield base can include one or more locking members for engaging theneedle cannula shaft. Locking member 34 is shown as integral with thecap 36, and having a base connected to one of the opposing side walls ofthe cap near the opening of cavity 38. The locking member 34 isdeflectable towards the side wall to which it is connected as the capand connected needle shield base are urged over a needle cannula.

[0037] The cap 36 can be secured to the distal end of the needle shieldbase by an adhesive, by welding or by mechanical connectors. The distalend portion of the needle shield base is preferably open-ended while thecap preferably has a closed or partially closed distal end that isintended to shield the pointed end of the needle cannula. The proximalend portion of the cap is open-ended. The needle shield/cap assembly canbe manufactured in several different ways. Both the needle shield baseand cap can be injection molded from a suitable plastic material such aspolypropylene, polyethylene or combinations thereof. The needle shieldbase can be molded to the desired length, or made large enough toaccommodate a range of needle cannula lengths and then cut, ifnecessary, to the desired length. The cap is then secured to the needleshield.

[0038] While the distal end portion of the needle shield base 26preferably defines an elongate cavity, such a cavity is not critical,and the cap can define the only cavity of the device. The proximal endportion of the needle shield base may include projections or tabs 40 forlockingly engaging the needle hub 22 or base member 24.

[0039] The base member 24 of the preferred embodiment includes aprojection 42 having notches 44 for receiving the locking projections 40at the proximal end of the needle shield base 26, as shown in FIG. 3.The base member further includes a channel 46 having arcuate walls forreceiving the hinge pin 29 on the needle shield base. As shown in FIGS.2 and 10-12, the channel 46 is positioned between a C-shaped projection48 and a ramnp 50. A cylindrical recess 51 in the base member 24 isprovided for receiving the proximal end of the needle cover 28.

[0040] The needle hub includes a proximal end adapted for connection toa medical device such as a syringe 52. Various types of connectors areknown and considered to be within the purview of the present invention.When secured to the medical device, fluid communication is establishedbetween the needle cannula 30 and the inner chamber 54 of the device.

[0041] The needle shield base 26 and associated locking assembly 32,which together comprise a needle shield, can be pivoted about the hingepin 29 between the open position shown in FIGS. 4 and 6 and the closedposition shown in FIGS. 5 and 8. The locking member 34 is displacedtowards a side wall of the cap 36 as the needle cannula 30 enters thecavity 38. Once the needle cannula has moved sufficiently into thecavity, the locking member 34 springs back to its original position,thereby entrapping the needle cannula as shown in FIG. 9.

[0042]FIG. 13 shows a needle shield base 26 having a distal end portion27 manufactured to a selected length. The locking assembly 32 may besecured to the shield base as manufactured if the locking member 34 willbe engageable with the needle cannula 30 with which it is used. If theneedle shield base is to be used to protect a shorter needle cannula, itcan be severed at a selected point, as indicated by way of example atline 54. FIGS. 15 and 16 illustrate needle shield bases 26′, 26″ severedto relatively short and long lengths, respectively, prior to securementof the locking assembly 32.

[0043] A second embodiment of the invention is shown in FIG. 17. In thisembodiment, the needle shield base 126 is manufactured to a selectedlength that can preferably accommodate a plurality of lengths of needlecannulas. The distal end portion 127 of the needle shield base includesa top wall 128, opposing side walls 130 and an end wall 132 that definean elongate cavity. A pair of openings 134 extend through the top wall128. The same numerals are employed to designate similar elements foundin the shield of the previous embodiment.

[0044] A locking assembly 136 is provided for coupling to the needleshield base. The locking assembly includes an elongate rail 138 havingone or more locking members 140. Each locking member includes adownwardly extending wall 142 and a projection 144 preferably extendingupwardly at an acute angle with respect to the wall 142. The lockingmembers are resilient and can be deflected by the shaft of a needlecannula. They will also spring back to their original positions once aneedle cannula is entrapped. A pair of projections 146 extend upwardlyfrom the rail 138. Each projection has an enlarged end portion that canbe forced through one of the openings 134 in the top wall of the needleshield base, thereby providing a locking engagement with the shield.Other types of mechanical locking elements can be employed to couple theshield base 126 and the locking assembly 136. These elements can also becoupled by an adhesive heat staking or other suitable means.

[0045]FIGS. 18-20 show a third embodiment of the invention. In thisembodiment, the needle shield assembly 200 includes a needle shield base226 having a proximal end portion similar to those described above. Thesame numerals are accordingly used to designate similar parts. Thedistal end portion 227 thereof is in the form of an elongate rail. Apair of holes 228 extend through the rail. A locking assembly 230 isprovided for coupling to the distal end portion of the needle shieldbase. It includes a top wall 232 and a pair of opposing side walls 234that define an elongate channel 236. A pair of projections 238 extendfrom the top wall 232 of the locking assembly. Each projection includesa shaft 239 having an enlarged head 240 that may be tapered tofacilitate entrance into the holes 228 in the distal end portion of 227of the needle shield. These elements are best shown in FIG. 20. One ormore projections 242, each preferably integral with one of the sidewalls 234. The projection is connected to the side wall 234 near thechannel opening, and is deflectable towards the side wall about itsconnection. The locking assembly may be secured to the needle shieldbase in either of two orientations as shown in FIGS. 18 and 19. Needlesof different lengths can accordingly be accommodated with the sameneedle shield base and locking assembly. As discussed above, differenttypes of locking arrangements can be used to couple the needle shieldbase and locking assembly.

[0046] A fourth embodiment of the invention is shown in FIG. 21. Aneedle shield assembly 300 is comprised of a needle shield base 326similar to those of the first two embodiments. The same numerals areaccordingly employed to designate common elements of the needle shieldbase, hub and base member found in these embodiments. The distal endportion 327 of the needle shield base 326 includes a pair of holes 328extending through the top wall thereof and opening into the elongateneedle shield channel. A locking assembly 330 is provided for connectionto the needle shield base. The locking assembly 330 is comprised of anelongate rail 332 having a pair of projections 333 extending upwardlyfrom the top surface of the rail and a pair of locking members 334extending downwardly from the rail. Each projection 333 includes a shafthaving an enlarged head that is sized to snap through holes 328 indistal end portion 327 of needle shield base 326, thereby permanentlycoupling the needle shield and locking assembly. Locking members 334 areformed as generally V-shaped structures beneath the rail 332. They aredeflectable by a needle cannula shaft as the needle shield (comprisingthe needle shield base 326 and locking assembly 330) is closed, andspring back to their original positions once the needle shield is fullyclosed. The needle cannula shaft is thereby entrapped within theV-shaped portions of the locking members 334. It will be appreciatedthat a greater or lesser number of locking members can be employed.

[0047] The proximal end portion of the locking assembly 330 isbifurcated as shown in FIGS. 21-22 to accommodate the base member 24.Each opposing wall 336 thereof includes an inwardly extending projection338. When the locking assembly is coupled to the needle shield base, theprojections are capable of engaging the projection 42 on the base member24, thereby locking the needle shield in the closed, needle protectingposition.

What is claimed is:
 1. A needle shield assembly comprising: a needle hubhaving a proximal end and a distal end; a needle cannula secured to thedistal end of said hub; a needle shield base having a proximal endportion and a distal end portion, said proximal end portion beingpivotably connected to said needle hub; a discrete locking assemblycoupled to said distal end portion of said needle shield base, saiddiscrete locking assembly including a needle engagement member; and atleast one of said needle shield base and said locking assembly includinga cavity for receiving at least a portion of said needle cannula.
 2. Theneedle shield assembly of claim 1 wherein said locking assemblycomprises a cap including a first cavity, said needle engagement memberextending into said first cavity.
 3. The needle shield assembly of claim2 wherein said distal end portion of said needle shield base includes ashield portion having a second cavity, said first and second cavitiesbeing contiguous.
 4. The needle shield assembly of claim 3 wherein saidshield portion of said needle shield base has an open distal end andsaid cap has an open proximal end joined to said open distal end of saidshield portion.
 5. The needle shield assembly of claim 3 wherein saidcap has a closed distal end.
 6. The needle shield assembly of claim 1wherein said needle shield base and said locking assembly includecomplementary locking members connecting said needle shield base andsaid locking assembly.
 7. The needle shield assembly of claim 6 whereinsaid locking assembly includes an elongate rail, said needle engagementmember being connected to said rail.
 8. The needle shield assembly ofclaim 6 wherein said needle shield base includes an elongate cavity,said rail being positioned within said elongate cavity.
 9. The needleshield assembly of claim 6 wherein said distal end portion of saidneedle shield base includes an elongate rail and said locking assemblyincludes a body defining an elongate cavity, said body being connectedto said elongate rail.
 10. The needle shield assembly of claim 1 whereinsaid distal end portion of said needle shield base includes an elongaterail and said locking assembly includes a body defining an elongatecavity, said body being connected to said elongate rail.
 11. The needleshield assembly of claim 1 wherein said needle shield base includes anelongate cavity, and said locking assembly is positional at leastpartially in said elongate cavity.
 12. The needle shield assembly ofclaim 11 wherein said locking assembly includes means for locking saidneedle shield base and said locking assembly to said needle hub.
 13. Amethod of manufacturing a needle shield, comprising: providing a needleshield base having a proximal end portion and a distal end portion, saidproximal end portion including a connector for pivotably connecting saidneedle shield base to a medical device; providing a locking assemblyincluding a needle engagement member; and connecting said lockingassembly to said distal end portion of said needle shield base.
 14. Themethod of claim 13 wherein said locking assembly comprises a capincluding a first cavity, wherein said needle engagement member extendsinto said first cavity.
 15. The method of claim 14 wherein said distalend portion of said needle shield base includes a shield portion havinga second cavity, positioned so that upon connecting said cap to saidshield portion, said first and second cavities are contiguous.
 16. Themethod of claim 15 wherein said shield portion has an open distal endand said cap has an open proximal end, including the step of connectingsaid open distal end of said shield portion with said open proximal endof said cap.
 17. The method of claim 13 wherein said needle shield baseand said locking assembly include complementary locking members,including the step of connecting said needle shield base and saidlocking assembly by coupling said complementary locking members.
 18. Themethod of claim 17 wherein said locking assembly includes an elongaterail, said needle engagement member being connected to said rail. 19.The method of claim 18 wherein said needle shield base includes anelongate cavity, including the step of positioning said rail within saidcavity.
 20. The method of claim 17 wherein said distal end portion ofsaid needle shield base includes an elongate rail and said lockingassembly includes a body defining an elongate cavity, including the stepof connecting said body of said locking assembly to said elongate rail.21. The method of claim 13 wherein said distal end portion of saidneedle shield base includes an elongate rail and said locking assemblyincludes a body defining an elongate cavity, including the step ofconnecting said body of said locking assembly to said elongate rail. 22.The method of claim 13 wherein said needle shield base includes anelongate cavity, including the step of positioning said locking assemblyat least partially within said elongate cavity.